Celltrion has struck a deal with 180 Life Sciences to supply anti-TNF products to support the company’s work in pursuing new indications for off-patent biologics.

Stada has struck a deal to partner with Italy’s NTC to market a portfolio of ophthalmic brands in the MENA region. At the same time, the German generics giant has agreed a distribution deal for the Czech Republic with Latvia’s Kalceks.

Alvotech has suffered a setback in its attempt to gain the first US FDA approval for a higher-strength biosimilar adalimumab rival to Humira, after obstacles preventing facility inspections led the agency to defer action on the firm’s AVT02 candidate.

The FDA has awarded biosimulation specialist Certara a further grant to verify and expand models for assessing virtual bioequivalence, to help enable safer, faster and more cost-effective generic drug development.

Samsung Bioepis has celebrated the FDA’s first ever approval of an ophthalmic biosimilar with its endorsement of the firm’s Byooviz ranibizumab rival to Lucentis. The firm has also signaled a surprising expected launch date in the US, as well as offering expectations for launch in Europe where the biosimilar was also recently approved.

Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.